Ventilator-Associated Pneumonia in Critically Ill COVID-19 vs. Non-COVID-19 Patients
- Conditions
- InfectionsOrgan Failure, MultipleVentilator Associated PneumoniaCritical IllnessSuperinfectionSeptic Shock
- Interventions
- Other: COVID-19
- Registration Number
- NCT05972980
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
The COVID-19 pandemic has led to an increased incidence of ventilator-associated pneumonia (VAP) among critically ill patients. However, in a context of high prevalence of multidrug-resistant organisms (MDROs) there is a lack of direct comparison between the incidence of VAP in COVID-19 and non-COVID-19 cohorts.
The investigators conducted a prospective, single-center cohort study comparing COVID-19 patients admitted to the intensive care unit (ICU) of the Città della Salute e della Scienza University Hospital in Turin, Italy, between March 2020 and December 2021 (COVID-19 group), with a historical cohort of ICU-mixed patients admitted between June 2016 and March 2018 (NON-COVID-19 group).
- Detailed Description
The study aims to explore the occurrence and characteristics of ventilator-associated pneumonia (VAP) in critically ill patients during two distinct periods: the pre-pandemic era and the COVID-19 pandemic. VAP, a serious complication arising from invasive mechanical ventilation (IMV) lasting at least 48 hours, had a crude incidence of 5% to 40% before the COVID-19 pandemic, whereas COVID-19 patients experienced even higher rates, reaching 48-64%.
The COVID-19 pandemic triggered an unprecedented rise in ICU admissions due to severe acute respiratory syndrome caused by the SARS-CoV-2 virus, leading to a considerable number of patients requiring IMV. Mechanical ventilation is a known risk factor for VAP, and COVID-19 exacerbates this risk due to factors like disease-induced immunoparalysis, prolonged mechanical ventilation and sedation, and more frequent application of prone positioning.
Despite the widespread need for prolonged mechanical ventilation in COVID-19 patients, few studies have compared the impact of VAP between pre-pandemic and COVID-19 populations. Additionally, limited research exists on the risk factors for VAP development in COVID-19 patients and the use of scoring systems like SAPS and SOFA as prognostic factors in this specific context. Although the coVAPid study offered insights into VAP risk factors in COVID-19 patients compared to those with influenza, it inadequately addressed the prevalence of multidrug-resistant organisms (MDROs) in this population, particularly carbapenem-resistant Acinetobacter baumannii (CR-Ab). Hence, this study aims to bridge this knowledge gap by investigating VAP's impact in a setting characterized by a high incidence of multidrug resistance.
To achieve this, the study will take place at the Molinette Hospital of the "Città della Salute e della Scienza" University Hospital in Turin, Italy, over a six-year period, spanning from January 2016 to December 2022. This retrospective, observational, and monocentric study will focus on two distinct cohorts: the pre-pandemic cohort (NON-COVID-19) and the COVID-19 cohort.
Researchers will identify ventilator-associated pneumonia (VAP) episodes based on the current definitions provided by the European Center for Disease Prevention and Control (ECDC). Patients will be monitored until hospital discharge to assess outcomes, including ICU mortality, overall mortality, duration of ICU stay, and duration of hospitalization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- All adult patients diagnosed with ventilator-associated pneumonia
- Patients admitted to the intensive care units
- Patients who underwent mechanical ventilation for a duration longer than 48 hours
- Patients in extreme end-of-life conditions
- Pregnant individuals
- Patients under 18 years of age
- Patients who did not meet the diagnosis criteria for ventilator-associated pneumonia
- Patients who underwent mechanical ventilation for a duration equal to or shorter than 48 hours
- Ventilator-associated tracheobronchitis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 cohort COVID-19 Patients with Ventilator Acquired Pneumonia with COVID-19. Confirmation of pneumonia was achieved by using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique on a sample collected from the lower respiratory tract. The COVID-19 cohort consists of patients admitted at the "Città della Salute e della Scienza" University Hospital (Turin, Italy) in two intensive care units at Molinette Hospital, dedicated to treating critically ill patients with COVID-19.
- Primary Outcome Measures
Name Time Method Mortality 28 days Mortality within the first 28 days from ICU admission
- Secondary Outcome Measures
Name Time Method Ventilator acquired pneumonia incidence 28 days Incidence of ventilator acquired pneumonia
Multidrug-resistant micro-organisms incidence From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months Incidence of Multidrug-resistant micro-organisms
Difficult to treat pathogens incidence From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months Incidence of difficult to treat pathogens
Intensive care unit length of stay From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months Duration of intensive care unit length of stay
Hospital mortality From date of enrollment until the date of hospital discharge, assessed up to 6 months Mortality during hospital stay
Mechanical ventilation days From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months Days of mechanical ventilation length of stay
ICU mortality From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months Mortality during intensive care unit stay
Hospital length of stay From date of enrollment until the date of hospital discharge, assessed up to 6 months Duration of hospital length of stay
Trial Locations
- Locations (1)
AOU Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy